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Radiation Therapy, Cisplatin, Fluorouracil, and Cetuximab in Treating Patients With Locally Advanced Anal Cancer

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ClinicalTrials.gov Identifier: NCT00955240
Recruitment Status : Unknown
Verified July 2011 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : August 10, 2009
Last Update Posted : July 11, 2011
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE August 7, 2009
First Posted Date  ICMJE August 10, 2009
Last Update Posted Date July 11, 2011
Study Start Date  ICMJE March 2009
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2009)
Objective response (complete and partial) according to RECIST criteria at 8 weeks after completion of study treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00955240 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2009)
  • Survival rate at 3 and 5 years
  • Colostomy-free survival at 3 and 5 years
  • Duration of objective response
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiation Therapy, Cisplatin, Fluorouracil, and Cetuximab in Treating Patients With Locally Advanced Anal Cancer
Official Title  ICMJE Phase II Nonrandomized Multicenter Study of the Impact of Radiochemotherapy (65 Gy + Cisplatin + 5FU) Combined With Cetuximab in Patients Presenting With Locally Advanced Anal Cancer
Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving radiation therapy together with combination chemotherapy and cetuximab may kill more tumor cells.

PURPOSE: This phase II trial is studying giving radiation therapy together with cisplatin, fluorouracil, and cetuximab to see how well it works in treating patients with locally advanced anal cancer.

Detailed Description

OBJECTIVES:

Primary

  • Evaluate the objective response (complete and partial) 8 weeks after completion of study treatment comprising radiotherapy, chemotherapy (fluorouracil and cisplatin), and cetuximab followed by additional radiotherapy in patients with locally advanced anal cancer.

Secondary

  • Evaluate colostomy-free survival.
  • Evaluate the local control rate (objective response and stabilization) at 8 weeks.
  • Evaluate relapse-free survival at 5 years.
  • Evaluate the intermediate objective response at the end of week 5 of radiotherapy.
  • Evaluate overall survival at 5 years.
  • Evaluate the duration of response.
  • Evaluate acute toxicities according to CTCAE v3.0.
  • Evaluate late toxicities at 5 years according to CTCAE v3.0.
  • Study the tumor markers associated with response (survival without relapse) and toxicity.
  • Study the genotypes of Fc-receptor immunoglobulins (FCGR2A and FCGR3) and their association with skin toxicity, objective survival, and relapse-free survival.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV on days 0, 7, 14, 21, 28, and 35; fluorouracil IV on days 7-10 and 35-38; and cisplatin IV over 2 hours on days 7 and 35. Beginning on day 7, patients also undergo radiotherapy 5 days a week for 5 weeks (weeks 2-6). Two weeks after finishing this treatment, patients undergo additional radiotherapy* 5 days a week for 2 weeks (weeks 9 and 10).

NOTE: *Some patients may undergo brachytherapy.

Blood and tissue samples are collected for further analysis.

After completion of study treatment, patients are followed up for 4 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Primary Purpose: Treatment
Condition  ICMJE Anal Cancer
Intervention  ICMJE
  • Biological: cetuximab
  • Drug: cisplatin
  • Drug: fluorouracil
  • Other: laboratory biomarker analysis
  • Radiation: radiation therapy
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 7, 2009)
77
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed anal cancer

    • Squamous cell disease
    • Locally advanced, non-metastatic disease
    • One of the following clinical TNM stages:

      • T2, N0, M0 (largest diameter ≥ 3 cm)
      • T3-T4, N0, M0
      • Any T, N1-N3, M0
  • No undifferentiated small cell carcinoma or adenocarcinoma
  • Measurable disease according to RECIST criteria
  • Undergone endorectal ultrasound or MRI to evaluate the primary tumor
  • Undergone thoraco-abdomino-pelvic scan to evaluate tumor extension
  • Disease suitable to receive radiotherapy and chemotherapy

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Leukocytes ≥ 4,000/mm^3
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL
  • Creatinine clearance > 60 mL/min
  • ALT and AST ≤ 5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Total bilirubin ≤ 1.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • No history of cancer within the past 8 years except for in situ cervical cancer or previously treated basal cell carcinoma of the skin
  • No contraindications to any component of study therapy
  • No serious uncontrolled illness
  • No symptomatic grade 1 angina pectoris or angina pectoris ≥ grade 2
  • No congestive heart failure
  • No peripheral sensory neuropathy
  • No uncontrolled diabetes
  • No HIV positivity
  • No geographical, social, or psychological situations that preclude medical follow up
  • Affiliated with a social security system
  • No patient deprived of liberty or under trusteeship

PRIOR CONCURRENT THERAPY:

  • Patients with a diverting colostomy are eligible
  • No prior excision of this tumor
  • No prior chemotherapy or radiotherapy for the treatment of this cancer or any other history of radiotherapy or pelvic brachytherapy
  • No concurrent coumarin anticoagulants, phenytoin, sorivudine or brivudine, antacids, or allopurinol
  • Not registered in another clinical trial with an experimental drug
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00955240
Other Study ID Numbers  ICMJE CDR0000642638
FRE-FNCLCC-ACCORD-16-0708
EU-20941
EUDRACT-2007-0 07029-38
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE UNICANCER
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric Deutsch, MD Gustave Roussy, Cancer Campus, Grand Paris
PRS Account National Cancer Institute (NCI)
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP